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Tikcro Technologies Reports First Quarter 2019 Results

On June 26, 2019 Tikcro Technologies Ltd. (OTCQB: TIKRF), a pre-clinical stage developer of antibodies for cancer immune-therapy, reported its financial results for the first quarter ended March 31, 2019 (Press release, Tikcro, JUN 26, 2019, View Source [SID1234537286]).

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"We are focused on the progress of our cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody, which has shown strong comparative results in pre-clinical cancer treatment assays," said Aviv Boim, CEO of Tikcro. "At recent industry events a number of biotechnology companies and clinical centers have reported results of trial for the combination treatment of PD1 or PD-L1 antibodies with a CTLA-4 antibody. Several molecule structures and a number of experimental clinical indications in oncology were presented. These development efforts aim to broaden clinical indications, increase the efficacy and reduce immune-related adverse effects of a CTLA-4 antibody treatment. CTLA-4 antibody treatment gains additional attention, however, along with increased competition. Based on pre-clinical results, our novel CTLA-4 antibody has the potential to address the needs to offer higher efficacy and lower side effects."

Several established and emerging pharma companies, including Tikcro, are pursuing new CTLA-4 antibodies to further broaden its clinical scope and to reduce immune related adverse effects.

Financial Results for the First Quarter Ended March 31, 2019
Net loss for the first quarter of 2019 was $271,000, or $0.03 per diluted share, compared to a net loss of $377,000, or $0.04 per diluted share, for the same period last year.

As of March 31, 2019, the company reported $4.95 million in cash, cash equivalents and short-term bank deposits.

Insmed Announces Closing of Public Offering of Common Stock

On June 26, 2019 Insmed Incorporated (Nasdaq: INSM) reported the closing on June 25, 2019 of the issuance of an additional 1,442,307 shares of common stock pursuant to the full exercise of the underwriter’s overallotment option related to the previously announced public offering of its common stock (Press release, Insmed, JUN 26, 2019, View Source [SID1234537285]). The underwriters were granted 30-day options to purchase up to an additional 1,042,307 shares of common stock from Insmed and up to 400,000 shares of common stock from William H. Lewis, the Company’s Chairman and Chief Executive Officer at a public offering price of $26.00 per share. The net proceeds to the Company from the sale of the additional shares, after deducting underwriting discounts and commissions but before expenses, were approximately $25.6 million. The Company did not receive any proceeds from the sale of Mr. Lewis’ shares.

Insmed intends to use its net proceeds from this offering to continue to commercialize ARIKAYCE (amikacin liposome inhalation suspension); conduct further trials of ARIKAYCE, including Insmed’s required confirmatory trial to assess and describe the clinical benefit of ARIKAYCE in patients with Mycobacterium avium complex (MAC) lung disease; fund further clinical development of INS1007 and INS1009; invest in increased third‑party manufacturing capacity for ARIKAYCE; fund business expansion activities in Europe and Japan; fund working capital, potential debt repayment, capital expenditures, and general research and development; and for other general corporate purposes, which may include the acquisition or in‑license of additional compounds, product candidates, technology or businesses.

Morgan Stanley & Co. LLC, SVB Leerink LLC and Goldman Sachs & Co. LLC acted as joint book-running managers for the offering. Credit Suisse Securities (USA) LLC, Stifel, Nicolaus & Company, Incorporated and H.C. Wainwright & Co. acted as co-managers for the offering.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (SEC), as amended by Post-Effective Amendment No. 1 thereto, and became automatically effective upon filing. A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, telephone: 1-800-808-7525, ext. 6132 or email at [email protected]; and Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

Yisheng Biopharma Receives IND Clearance from China NMPA to Initiate Clinical Trial of YS-ON-001 in the Treatment of Advanced Solid Tumors

On June 26, 2019 Yisheng Biopharma Co., Ltd. ("Yisheng Biopharma"), a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immunological biologics and vaccines, reported that it has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China to initiate a clinical trial of YS-ON-001, a first-in-class immuno-oncology product for the treatment of advanced solid tumors (Press release, Yisheng US Biopharma, JUN 26, 2019, View Source [SID1234537284]).

"The IND clearance for YS-ON-001 by the China NMPA marks the third product entering clinical development based on our PIKA technology platform. This milestone once again demonstrates Yisheng’s capability and commitment to the advancement of immunological technology for biopharmaceutical market. PIKA immuno-modulating technology has been officially recognized three times since 2013 as a "National New Medical Innovation" by the Chinese government. We plan to move forward with the clinical development of YS-ON-001 in China to bring it to the market as efficiently as possible. Yisheng Biopharma will continue to expand our portfolio in new immunological therapeutics and vaccines to benefit patients in need of new options," commented by David Shao, Ph.D., President and Chief Executive Officer of Yisheng Biopharma.

About YS-ON-001

YS-ON-001 consists of a complex of protein and PIKA immunomodulating agent and is designed to reduce immunosuppressive effects within the tumor microenvironment and enhance antitumor immune responses. YS-ON-001 is capable of increasing CD4+ and CD8+ T-cell responses, increasing the proportion of natural killer and natural killer T cells and promoting higher expression level of PD-L1 receptors in tumor tissues. YS-ON-001 also showed the reduction in the number of T regulatory cells and myeloid-derived suppressor cells. YS-ON-001 can be delivered via intramuscular, subcutaneous or intratumoral injection and has demonstrated a highly effective tumor growth inhibition in preclinical studies with models of breast, lung, liver, colorectal, prostate and other cancers.

YS-ON-001 has received Orphan Drug Designation from the U.S FDA for development of the treatment for both hepatocellular cancer and pancreatic cancer, and is approved for use in Cambodia as YivykaTM.

Morphic Announces Pricing of Upsized Initial Public Offering

On June 26, 2019 Morphic Holding, Inc. ("Morphic"), a biopharmaceutical company discovering and developing oral small-molecule integrin therapeutics, reported the pricing of its upsized initial public offering of 6,000,000 shares of its common stock at a price to the public of $15.00 per share (Press release, Morphic Therapeutic, JUN 26, 2019, View Source [SID1234537281]). The shares are expected to begin trading on The Nasdaq Global Market on June 27, 2019 under the symbol "MORF." The offering is expected to close on July 1, 2019, subject to customary closing conditions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Morphic, are expected to be approximately $90.0 million. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 900,000 shares of common stock.

Jefferies LLC, Cowen and Company, LLC, BMO Capital Markets Corp. and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on June 26, 2019. The offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering, when available, may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected], from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (631) 592-5973 or by email at [email protected]; from BMO Capital Markets Corp. at 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, by telephone at (800) 414-3627 or by email to [email protected]; or from Wells Fargo Securities, LLC 375 Park Avenue, New York, New York 10152, Attention: Equity Syndicate Department, or by calling (800) 326-5897, or by emailing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Blue Earth Diagnostics Announces Highlights of Technical University of Munich Presentations on Initial Clinical Experience with 18F-rhPSMA-7 PET Imaging in High Risk Primary and Biochemical Recurrent Prostate Cancer

On June 26, 2019 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported results from early clinical experience in Germany with positron emission tomography (PET) (PET/CT or PET/MRI) imaging using a radiohybrid Prostate Specific Membrane Antigen-targeted compound (18F-rhPSMA-7) (Press release, Blue Earth Diagnostics, JUN 26, 2019, View Source [SID1234537280]). The presentations were made by the Technical University of Munich (TUM) and Ludwig-Maximilian-University (LMU), Munich. Blue Earth Diagnostics acquired exclusive rights to a broad family of rhPSMA agents in 2018. Presentations included early clinical experience with 18F-rhPSMA-7 PET in the detection of biochemical prostate cancer recurrence in patients after radical prostatectomy, after radiation therapy and in high risk primary prostate cancer patients. Additional presentations described the biodistribution profile of 18F-rh-PSMA-7, the initial clinical proof-of-concept evaluation, chemical labeling and GMP production of the radiohybrid compound, and dosimetry and biodistribution characteristics for 18F-rhPSMA-7 and one of its four isomers, 18F-rhPSMA-7.3. Results were presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI), from June 22 – 26, 2019 in Anaheim, Ca.

NOTE: this early clinical experience with 18F-rhPSMA-7 by TUM in Germany, consistent with the German Medicinal Products Act 13 (2b), reflects use of an investigational agent for which safety and efficacy have not been established by the U.S. Food and Drug Administration.

"We are very pleased that TUM and LMU are able to share their initial clinical experiences with 18F-rhPSMA-7 in multiple presentations to the nuclear medicine community at SNMMI," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Blue Earth Diagnostics’ acquisition of rhPSMA has expanded our technologically advanced PET imaging portfolio, and complements approved, commercially available Axumin (fluciclovine F 18). We believe that both agents may ultimately provide physicians and their patients living with prostate cancer the ability to select the diagnostic agent most appropriate to each specific clinical situation. Based on results from these studies, we are progressing the isomer 18F-rhPSMA-7.3 as a lead imaging candidate for further development."

"Effective staging of primary prostate cancer and determining the extent and location of recurrent disease can inform an appropriate clinical management plan specific for each patient," said Wolfgang Weber, MD, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM. "This is an important consideration for physicians and their patients, as between 30 – 40% of men with prostate cancer will develop local or distant recurrences after radical prostatectomy or radiation therapy. Our early clinical use of 18F-rhPSMA-7 PET imaging at TUM reflects our experiences in prostate cancer patients with biochemical recurrence after radical prostatectomy, after radiation therapy and in primary disease. These preliminary data are encouraging and support further research with rhPSMA."

"Initial experience with 18F-rhPSMA-7 at TUM has allowed us to investigate the potential diagnostic performance of a new class of PSMA-targeting agents that enable efficient labelling with imaging radioisotopes such as 18F for PET imaging," said Matthias Eiber, MD, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM. "Based on the half-life of the 18F radioisotope, 18F-labeled PSMA-targeted imaging agents can offer efficient distribution and broad availability, outside of select academic research institutions, as well as rapid production, consistent, centralized manufacturing and high resolution PET scans, all of which are important considerations in detecting and localizing prostate cancer."

Highlights of TUM 18F-rhPSMA-7 PET/CT Clinical Presentations at SNMMI

In an oral presentation, "18F-rhPSMA-7 positron emission tomography (PET) for the detection of biochemical recurrence of prostate cancer following curative-intent radiation therapy," Dr. Harun Ilhan of LMU, Munich, presented results of a retrospective analysis of 78 patients who had biochemical recurrence of prostate cancer after primary radiation therapy. 18F-rhPSMA-7 PET/CT demonstrated a detection rate (DR) of 94% (73/78).
In second oral presentation, "18F-rhPSMA-7 positron emission tomography (PET) for the detection of biochemical recurrence of prostate cancer following radical prostatectomy," Dr. Matthias Eiber of TUM described results from a retrospective analysis of 532 patients with biochemically recurrent prostate cancer after radical prostatectomy in which 18F-rhPSMA-7 PET/CT or PET/MRI demonstrated a DR of 79.5% (423/532) at a median PSA level of 0.97 ng/mL. The DR in patients with a PSA of 0.2-<0.5ng/mL was 63.8% (81/127).
Dr. Markus Kroenke of TUM presented results of a retrospective analysis of 58 patients with high risk primary prostate cancer which indicated that 18F-rhPSMA-7 PET/CT or PET/MRI demonstrated sensitivity of 72% (13/18), specificity of 93% (37/40) and diagnostic accuracy 86% (50/58), when compared to histopathological findings in a poster presentation, "Histologically-confirmed diagnostic efficacy of 18F-rhPSMA-7 positron emission tomography for N-staging of patients with high risk primary prostate cancer."
Dr. Oh of TUM and Seoul National University Boramae Medical Center presented a poster, "Quantitative and qualitative analysis of biodistribution and PET image quality of novel radiohybrid PSMA ligand, 18F-rhPSMA-7, in patients with prostate cancer," which described a study to evaluate the optimum activity and imaging timepoint when using 18F-rhPSMA-7 to image patients with prostate cancer. The analysis showed stable uptake of 18F-rhPSMA-7 across multiple uptake times and administered activities, with an early imaging timepoint of 50 – 70 minutes recommended.
A poster presentation by Dr. Oh, "Preclinical dosimetry and human biodistribution of 18F-rhPSMA-7 and 18F-rhPSMA-7.3," compared preclinical dosimetry and human biodistribution characteristics of 18F-rhPSMA-7.3, one of the four isomers of 18F-rhPSMA-7, with that of the parent racemic compound. Standardized Uptake Value (SUV)mean for renal uptake and bladder retention were 55.2 and 10.2, respectively, for 18F-rhPSMA-7 and 35.5 and 2.0, respectively, for 18F-rhPSMA-7.3. Tumor uptake (SUVmean) from an analysis of 89 prostate cancer lesions was 20.0±20.2 for 18F-rhPSMA-7 and 32.5±42.7 for 18F-rhPSMA-7.3 (p<0.001).
In an oral presentation, "PSMA-targeted 18F-labeled Radiohybrid Inhibitors: Labeling chemistry and automated GMP production of 18F-rhPSMA-7," Daniel Di Carlo of TUM presented results on chemical labeling of radiohybrid radiopharmaceuticals, using 18F-rhPSMA-7 as the example compound. The labeling results were then used to establish rapid, fully automated, large-scale production of the compound in a clinical GMP environment.
Alexander Wurzer of TUM presented in an oral presentation, "PSMA-targeted 18F-labeled Radiohybrid Inhibitors: Concept, preclinical evaluation and first proof of concept study in men," which described preclinical evaluation of 18F-rhPSMA-7 and results of clinical proof-of-concept imaging, in which the compound demonstrated rapid renal clearance, minimal bladder uptake and enabled high-contrast imaging of lymph nodes and bone metastasis in men with metastatic castration-resistant prostate cancer.
Abstracts from the SNMMI Annual Meeting are published in the Journal of Nuclear Medicine: View Source

About rhPSMA

Blue Earth Diagnostics acquired exclusive, worldwide rights to radiohybrid Prostate Specific Membrane Antigen (PSMA)-targeted technology (rhPSMA) from Scintomics in 2018. rhPSMA originated from the Chair of Pharmaceutic Radiochemistry at the Technical University of Munich, Germany, by Alexander Wurzer and Hans Juergen Wester, and has been utilized clinically under German legislation at the Department of Nuclear Medicine for the diagnostic imaging of men with both primary and recurrent prostate cancer. 18F-rhPSMA consists of a prostate-specific membrane antigen (PSMA) receptor ligand, which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. 18F-rhPSMA has not received regulatory approval.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Presentations about 18F-rhPSMA-7 discuss experiences with an investigational agent for which the safety and efficacy have not been established by the FDA.

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full U.S. Axumin prescribing information is available at www.axumin.com.

About Blue Earth Diagnostics

Blue Earth Diagnostics is a leading molecular imaging diagnostics company focused on the development and commercialization of novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Formed in 2014, Blue Earth Diagnostics is led by recognized experts in the clinical development and commercialization of innovative nuclear medicine products. The company’s first approved and commercially